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Effectiveness of the HEAR-aware smartphone app for hearing-impaired adults aged 50+ years who are not ready for a hearing aid

How effective is the HEAR-aware smartphone app to increase readiness to take action of hearing-impaired adults aged 50+ years: a randomised controlled trial comparing the intervention group (4 weeks of HEAR-Aware app use) and the control group (no support)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93742150
Enrollment
84
Registered
2021-05-03
Start date
2021-05-06
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Readiness to take action on hearing loss Ear, Nose and Throat Hearing loss, unspecified

Interventions

Participants will be randomized at an individual level using Castor EDC. Castor EDC uses the standard method of variable block randomization. The researchers use random block sizes of 4 and 6 as these

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 50 years or older 2. Minimum pure tone threshold of 35 dB HL (hearing level) averaged across 1, 2, and 4 kHz in at least one ear 3. Visited a hearing aid dispensing practice for a hearing test appointment or a subsequent intake appointment in the past 1.5 years, but decided to not pursue a hearing aid trajectory 4. Does not (yet) want a hearing aid 5. Never tried a hearing aid before 6. Owns an email account, smartphone (iPhone iOS 10 and higher, i.e. iPhone 5 or newer; Android 4.4 or higher, i.e., phone bought in 2015 or newer), and uses apps 7. Is fluent in Dutch 8. Is willing to use the app regularly (on a daily basis)

Exclusion criteria

Exclusion criteria: 1. Main complaint is tinnitus (and not hearing impairment). The HEAR-aware app does not have tinnitus coping as its main focus 2. Patient is referred to and enrolled in care through a multidisciplinary audiological center. The app has overlapping content with care provided in such a center

Design outcomes

Primary

MeasureTime frame
Readiness to take action is measured using the Stages of Change measurement The Line, a discrete 11-point scale ranging from 0 (not ready at all) to 10 (highly ready) at baseline (T0), immediately after 4 weeks of app use (T1) and 4 weeks later (T2). The Line is generic in nature and does not specify what ‘taking action on hearing’ is. As the HEAR-aware app targets various target behaviors (e.g., communication strategies use, taking up hearing aids), Stages of Change will be measured both generically and specifically for these target behaviors.

Secondary

MeasureTime frame
1. Self-reported hearing disability measured using the Amsterdam Inventory for Auditory Disability and Handicap at T0, T1 and T2 2. Coping measured using the Communication Profile for the Hearing Impaired (CPHI) at T0, T1 and T2 3. Prior hearing help-seeking steps taken measured by asking whether or not participants have ever taken help-seeking steps (yes/no) (e.g. having visited a HAD/general practitioner/Ear Nose, and Throat doctor for a hearing test, performed a screening self-test) at T0, T1 and T2 4. Health-related quality of life measured using the EQ5D at T0, T1 and T2 5. Attitudes on hearing loss and hearing aids measured using the Attitude Questionnaire at T0, T1 and T2 6. Self-efficacy of hearing help-seeking measured using the Self-Efficacy of Hearing Help-Seeking Scale (SEHHS) at T0, T1 and T2

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026